MD-Vue™ Lateral Access System 54-SS-0012

GUDID 00840019936248

Suction Instruments - 12 Fr Long

PRECISION SPINE, INC.

Neurosurgical retraction system, spinal
Primary Device ID00840019936248
NIH Device Record Key6ce955aa-d2a5-4d18-8034-e7b32360232f
Commercial Distribution StatusIn Commercial Distribution
Brand NameMD-Vue™ Lateral Access System
Version Model Number54-SS-0012
Catalog Number54-SS-0012
Company DUNS079398589
Company NamePRECISION SPINE, INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840019936248 [Primary]

FDA Product Code

GADRetractor

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840019936248]

Moist Heat or Steam Sterilization


[00840019936248]

Moist Heat or Steam Sterilization


[00840019936248]

Moist Heat or Steam Sterilization


[00840019936248]

Moist Heat or Steam Sterilization


[00840019936248]

Moist Heat or Steam Sterilization


[00840019936248]

Moist Heat or Steam Sterilization


[00840019936248]

Moist Heat or Steam Sterilization


[00840019936248]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-15
Device Publish Date2025-07-07

On-Brand Devices [MD-Vue™ Lateral Access System]

00840019970877Table Arm Kit
00840019970860Table Arm Case
00840019970853Table Clamp
00840019970846Table Arm
00840019936248Suction Instruments - 12 Fr Long

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.